US11925551B2ActiveUtilityA1

Leaflet attachment frame for prosthetic valve

Assignee: EDWARDS LIFESCIENCES CORPPriority: Dec 14, 2007Filed: Mar 24, 2022Granted: Mar 12, 2024
Est. expiryDec 14, 2027(~1.4 yrs left)· nominal 20-yr term from priority
A61F 2/2418A61F 2/2412A61F 2/2415A61F 2/2409A61F 2210/0076A61F 2220/0075A61F 2230/0054
96
PatentIndex Score
2
Cited by
214
References
23
Claims

Abstract

An implantable prosthetic valve has an upper frame section and a lower frame section. The upper frame section has a plurality of struts and a first leaflet receiving surface at a lower portion of the upper frame section. The lower frame section has a second leaflet receiving surface at an upper portion of the lower frame section. An edge of a flexible leaflet is disposed between the first and second leaflet receiving surfaces to attach the leaflet to the upper and lower frame sections.

Claims

exact text as granted — not AI-modified
I claim: 
     
       1. An assembly comprising:
 a delivery catheter comprising a balloon; and 
 an implantable prosthetic valve that is radially compressible to a collapsed configuration and radially expandable to an expanded configuration, the implantable prosthetic valve comprising:
 a radially collapsible and expandable annular frame comprising a plurality of angled struts and having an outflow end and an inflow end, wherein the angled struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells defining the outflow end of the frame and a lowermost row of closed cells defining the inflow end of the frame; and 
 a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing commissure portions, each leaflet having a lower edge portion coupled to the frame and a width that decreases from the commissure portions to a lowermost end of the leaflet, and each commissure portion being paired with an adjacent commissure portion of an adjacent leaflet to form commissures of the leaflet structure; 
 
 wherein the frame comprises a plurality of vertical commissure support portions supporting respective commissures of the leaflet structure; 
 wherein the vertical commissure support portions are positioned axially along the frame entirely within the uppermost row of closed cells; 
 wherein the uppermost row of closed cells is formed partly by an uppermost, circumferentially extending row of angled struts of the frame interconnecting circumferentially adjacent commissure support portions; 
 wherein the commissure support portions are circumferentially spaced apart from each other by a plurality of closed cells of the uppermost row of closed cells; and 
 wherein the collapsed implantable prosthetic valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body. 
 
     
     
       2. The assembly of  claim 1 , wherein the lower edge portion of each leaflet is coupled to the frame along a leaflet attachment path that extends continuously along angled struts in multiple rows of angled struts positioned axially between lower ends of the commissure support portions and the inflow end of the frame. 
     
     
       3. The assembly of  claim 1 , wherein each commissure support portion is substantially straight. 
     
     
       4. The assembly of  claim 1 , wherein each angled strut of the plurality of angled struts is substantially straight. 
     
     
       5. The assembly of  claim 1 , wherein the plurality of circumferentially extending rows of closed cells further comprises an intermediate row of closed cells axially interposed between the uppermost row of closed cells and the lowermost row of closed cells; wherein the intermediate row of closed cells is formed partly by a circumferentially extending row of intermediate angled struts of the plurality of angled struts interconnecting one another; wherein the intermediate angled struts are connected to each other by U-shaped intermediate connection portions; and wherein each U-shaped intermediate connection portion forms a gap between adjacent ends of a corresponding pair of intermediate angled struts. 
     
     
       6. The assembly of  claim 5 , wherein each U-shaped intermediate connection portion comprises two vertical portions and a lateral portion extending between the two vertical portions; wherein the vertical portions are at least substantially parallel to a central longitudinal axis of the implantable prosthetic valve; wherein the lateral portion extends between and interconnects ends of the vertical portions; and wherein the vertical portions are spaced apart from each other to define the gap between the upper ends of the corresponding pair of intermediate angled struts. 
     
     
       7. The assembly of  claim 5 , wherein each intermediate angled strut is spaced apart from each angled strut that forms a portion of the uppermost row of closed cells. 
     
     
       8. The assembly of  claim 1 , wherein the angled struts of the uppermost row of angled struts are connected to each other at their upper ends by U-shaped connection portions; and wherein each U-shaped connection portion forms a gap between adjacent upper ends of a corresponding pair of angled struts. 
     
     
       9. The assembly of  claim 1 , wherein the frame comprises a material selected from the group comprising stainless steel and a cobalt-chromium alloy. 
     
     
       10. The assembly of  claim 1 , wherein the leaflet structure comprises pericardial tissue. 
     
     
       11. An assembly comprising:
 a delivery catheter comprising a balloon; and 
 an implantable prosthetic valve that is radially compressible to a collapsed configuration and radially expandable to an expanded configuration, the implantable prosthetic valve comprising:
 a radially collapsible and expandable annular frame comprising a plurality of angled struts and having an outflow end and an inflow end, wherein the angled struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells defining the outflow end of the frame and a lowermost row of closed cells defining the inflow end of the frame; and 
 a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing commissure portions, each leaflet having a lower edge portion coupled to the frame and a width that decreases from the commissure portions to a lowermost end of the leaflet, the lower edge portion extending from one commissure portion to the other commissure portion of the leaflet, and each commissure portion being paired with an adjacent commissure portion of an adjacent leaflet to form commissures of the leaflet structure; 
 
 wherein the frame comprises a plurality of commissure support posts supporting the commissures of the leaflet structure; 
 wherein the lower edge portion of each leaflet is coupled to the frame such that the lower edge portion of each leaflet extends along selected angled struts in multiple rows of angled struts positioned axially between the commissure support posts and the inflow end of the frame, wherein the lower edge portion of each leaflet extends continuously along and parallel to lengths of the selected angled struts; 
 wherein the collapsed implantable prosthetic valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body; 
 wherein the plurality of angled struts includes a first row of angled struts at least partially defining the uppermost row of closed cells and a second row of angled struts positioned axially upstream of the first row of angled struts; and 
 wherein the lower edge portion of each leaflet extends in a first direction from a lower end of one of the commissure support posts toward the inflow end of the frame along a first angled strut of the first row and a first angled strut of the second row, and then in a second direction toward the outflow end of the frame along a second angled strut of the second row and a second angled strut of the first row to a lower end of another one of the commissure support posts. 
 
     
     
       12. The assembly of  claim 11 , wherein the lower edge portion of each leaflet is sutured to the first angled strut of the first row, the first angled strut of the second row, the second angled strut of the second row, and the second angled strut of the first row. 
     
     
       13. The assembly of  claim 11 , wherein the lowermost end of each leaflet extends to the inflow end of the frame. 
     
     
       14. The assembly of  claim 11 , wherein the rows of angled struts include a lowermost row of angled struts partly forming the lowermost row of closed cells, wherein the lowermost row of angled struts comprises exactly four angled struts extending between the lower edge portions of adjacent leaflets on an upstream side of the lower edge portions of the adjacent leaflets. 
     
     
       15. The assembly of  claim 11 , wherein the rows of closed cells include a lowermost row of closed cells and an intermediate row of closed cells downstream of the lowermost row of closed cells, wherein exactly two cells of the lowermost row of closed cells and exactly one cell of the intermediate row of closed cells are positioned between the lower edge portions of adjacent leaflets on an upstream side of the lower edge portions of the adjacent leaflets. 
     
     
       16. The assembly of  claim 11 , wherein the frame is cylindrical. 
     
     
       17. An assembly comprising:
 a delivery catheter comprising a balloon; 
 an implantable prosthetic valve that is radially compressible to a collapsed configuration and radially expandable to an expanded configuration, the implantable prosthetic valve comprising:
 a radially collapsible and expandable annular frame comprising a plurality of angled struts and having an outflow end and an inflow end, wherein the angled struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells defining the outflow end of the frame and a lowermost row of closed cells defining the inflow end of the frame; and 
 a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing commissure portions, each leaflet having a lower edge portion coupled to the frame and a width that decreases from the commissure portions to a lowermost end of the leaflet, the lower edge portion extending from commissure portion to the other commissure portion of the leaflet, and each commissure portion being paired with an adjacent commissure portion of an adjacent leaflet to form commissures of the leaflet structure; and 
 
 a cloth member that is sutured to the frame; 
 wherein the frame comprises a plurality of commissure support posts supporting the commissures of the leaflet structure, wherein the commissure support posts have lower ends axially spaced from the inflow end of the frame; 
 wherein the lower edge portion of each leaflet is sutured to the cloth member along a suture-line that extends continuously along and parallel to lengths of angled struts in multiple rows of angled struts positioned axially between the commissure support posts and the inflow end of the frame; 
 wherein the lowermost end of each leaflet is at the inflow end of the frame; 
 wherein the collapsed implantable prosthetic valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body; and 
 wherein the commissure support posts are positioned axially along the frame entirely within the uppermost row of closed cells. 
 
     
     
       18. The assembly of  claim 17 , wherein the lowermost row of closed cells defines a plurality of inflow apices of the frame; and wherein the lower edge portion of each leaflet extends circumferentially from one of the inflow apices to an adjacent inflow apex. 
     
     
       19. The assembly of  claim 18 , wherein the plurality of angled struts includes a first row of angled struts at least partially defining the uppermost row of closed cells and a second row of angled struts positioned axially upstream of the first row of angled struts; and wherein the lower edge portion of each leaflet includes first and second opposing side edges, the first side edge being sutured to the cloth member along a first portion of the suture-line that extends in a first direction from a lower end of one of the commissure support posts toward the inflow end of the frame along a first angled strut of the first row and a first angled strut of the second row, and the second side edge being sutured to the cloth member along a second portion of the suture-line that extends in a second direction toward the outflow end of the frame along a second angled strut of the second row and a second angled strut of the first row to a lower end of another one of the commissure support posts. 
     
     
       20. The assembly of  claim 19 , wherein for each leaflet, the first side edge is sutured to the first angled strut of the first row and the first angled strut of the second row, and the second side edge is sutured to the second angled strut of the second row and the second angled strut of the first row. 
     
     
       21. The assembly of  claim 17 , wherein the cloth member comprises at least one of a biocompatible synthetic material, woven polyester, polyethylene terephthalate (PET), and polytetrafluoroethylene (PTFE). 
     
     
       22. An assembly comprising:
 a delivery catheter comprising a balloon; and 
 an implantable prosthetic valve that is radially compressible to a collapsed configuration and radially expandable to an expanded configuration, the implantable prosthetic valve comprising:
 a radially collapsible and expandable annular frame comprising a plurality of angled struts and having an outflow end and an inflow end, wherein the angled struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells defining the outflow end of the frame and a lowermost row of closed cells defining the inflow end of the frame; and 
 a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing commissure portions, each leaflet having a lower edge portion coupled to the frame and a width that decreases from the commissure portions to a lowermost end of the leaflet, the lower edge portion extending from one commissure portion to the other commissure portion of the leaflet, and each commissure portion being paired with an adjacent commissure portion of an adjacent leaflet to form commissures of the leaflet structure; 
 
 wherein the frame comprises a plurality of commissure support posts supporting the commissures of the leaflet structure; 
 wherein the lower edge portion of each leaflet is coupled to the frame such that the lower edge portion of each leaflet extends along selected angled struts in multiple rows of angled struts positioned axially between the commissure support posts and the inflow end of the frame, wherein the lower edge portion of each leaflet extends continuously along and parallel to lengths of the selected angled struts; 
 wherein the collapsed implantable prosthetic valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body; 
 wherein the rows of angled struts include a lowermost row of angled struts partly forming the lowermost row of closed cells; and 
 wherein the lowermost row of angled struts comprises exactly four angled struts extending between the lower edge portions of adjacent leaflets on an upstream side of the lower edge portions of the adjacent leaflets. 
 
     
     
       23. An assembly comprising:
 a delivery catheter comprising a balloon; 
 an implantable prosthetic valve that is radially compressible to a collapsed configuration and radially expandable to an expanded configuration, the implantable prosthetic valve comprising:
 a radially collapsible and expandable annular frame comprising a plurality of angled struts and having an outflow end and an inflow end, wherein the angled struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells defining the outflow end of the frame and a lowermost row of closed cells defining the inflow end of the frame; and 
 a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing commissure portions, each leaflet having a lower edge portion coupled to the frame and a width that decreases from the commissure portions to a lowermost end of the leaflet, the lower edge portion extending from commissure portion to the other commissure portion of the leaflet, and each commissure portion being paired with an adjacent commissure portion of an adjacent leaflet to form commissures of the leaflet structure; and 
 
 a cloth member that is sutured to the frame; 
 wherein the frame comprises a plurality of commissure support posts supporting the commissures of the leaflet structure, wherein the commissure support posts have lower ends axially spaced from the inflow end of the frame; 
 wherein the lower edge portion of each leaflet is sutured to the cloth member along a suture-line that extends continuously along and parallel to lengths of angled struts in multiple rows of angled struts positioned axially between the commissure support posts and the inflow end of the frame; 
 wherein the lowermost end of each leaflet is at the inflow end of the frame; 
 wherein the collapsed implantable prosthetic valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body; 
 wherein the lowermost row of closed cells defines a plurality of inflow apices of the frame; 
 wherein the lower edge portion of each leaflet extends circumferentially from one of the inflow apices to an adjacent inflow apex; 
 wherein the plurality of angled struts includes a first row of angled struts at least partially defining the uppermost row of closed cells and a second row of angled struts positioned axially upstream of the first row of angled struts; and 
 wherein the lower edge portion of each leaflet includes first and second opposing side edges, the first side edge being sutured to the cloth member along a first portion of the suture-line that extends in a first direction from a lower end of one of the commissure support posts toward the inflow end of the frame along a first angled strut of the first row and a first angled strut of the second row, and the second side edge being sutured to the cloth member along a second portion of the suture-line that extends in a second direction toward the outflow end of the frame along a second angled strut of the second row and a second angled strut of the first row to a lower end of another one of the commissure support posts.

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